Second time lucky

The original patent for pregabalin (Lyrica) as a treatment for epilepsy expired in 2014, paving the way for generic formulations, however, the firm had secured a second-use patent for pregabalin as a treatment for pain until July 2017.

In September, a ruling by the High Court of England and Wales raised a question mark over the strength of ‘second medical use’ patents. In what was widely touted as a landmark ruling, the court decided that Pfizer’s patent protection for pregabalin is invalid and, therefore, not infringed by a generic version from Actavis.

The original patent for pregabalin (Lyrica) as a treatment for epilepsy expired in 2014, paving the way for generic formulations, however, the firm had secured a second-use patent for pregabalin as a treatment for pain until July 2017.

As part of this complex and closely watched case, Pfizer also obtained an order compelling NHS England to issue guidance that only its branded product should be prescribed for pain, and sent letters to doctors and pharmacists threatening legal action if they did not comply.

However, High Court Judge Richard Arnold stressed that threats to medical professionals over correct prescribing of pregabalin were unjustified. The court also urged the Department of Health to put a system in place to minimise the potential for future disputes.

National system needed

This year an issue came to the fore with potentially significant implications for the future of medical innovation. The absence of a national system to help manage second-medical-use patents may put life-saving and life-changing discoveries at risk.

Moreover, it is a cause of confusion for health professionals and industry alike, and needs urgent resolution.

As science evolves, patients are increasingly benefiting from research into existing medicines, but to fuel such intensive work, second medical use patents must be respected. A system that fails to provide a mechanism for the implementation of the rights conferred by second medical use patents is one that is failing to keep pace with the evolution of R&D.

Our own experience has taught us much and we want to put this knowledge to good use. Put simply, we need a system that encourages innovation, while ensuring doctors and pharmacists can continue to focus on delivering the very best patient care.

This need has been recognised broadly, including the British Generic Medicines Association and the Association of the British Pharmaceutical Industry, and, as we look to 2016, our hope is that a growing consensus on this issue will be the catalyst for constructive debate and bring the clarity and reassurance we all so badly need.